The Fusion Of Power And Performance.

Transcription

The Fusion Of Power And Performance.
The Fusion of Power
and Performance.
A Spinal Implant
Designed to Fit. Naturally.
BENGAL is a spinal implant made of radiolucent carbon fiber
reinforced polymer (CFRP), a material that has a modulus of
elasticity approximating that of cortical bone. The result is
an implant that meets the structural requirements of
anterior column support, while optimizing the fusion
environment through an open, load-sharing design.
Lateral Openings
Facilitates vascularization.
Teeth
To prevent migration.
Large Center Opening
Allows more area for bone
graft-to-endplate contact.
Tantalum Beads
Allow for visualization and implant
placement verification.
Trapezoid Anatomical Shape
To achieve proper sagittal alignment.
A Precise
Various Footprints
Standard and Large are available
from 4mm to 16mm posterior
heights in 1mm increments, parallel
and lordotic. X Large is available
from 5mm to 16mm, parallel only.
Standard
12mm x 14.5mm
Large
14mm x 17mm
X Large
16mm x 20mm
Available parallel only
Anatomic Design
Available in both 7º and Parallel
formations allowing the surgeon to
achieve the proper sagittal alignment.
7º
Parallel (X Large Only)
Never
Fit has
Been This Easy.
The BENGAL Instruments have been designed
to allow for excellent apposition between the
endplate and the implant, ensuring maximal
opportunity for fusion.
Trials
Designed to allow accurate assessment of height
and footprint for proper implant selection.
Rasps
Designed to prepare the endplate for the precise
footprint prior to implant insertion.
Tamp
The footprint of the tamp is shaped to
match the internal geometry of the implant
to pack sufficient bone graft.
Impactor
Contoured to match the shape of the implant
and distribute the stresses on impaction.
Inserter
The threaded inserter is contoured to match the
shape of the implant. Easy insertion and removal
can be achieved with a single thread.
They lie undetected
in their environment…
Powerful teeth ready to grip
any surface…
Sleek, strong bodies
agile enough to conquer
any terrain…
DePuy AcroMed introduces the Big Cats,
a family of spinal fusion implants made
of Carbon Fiber Reinforced Polymer,
the premier fusion enabling material to
reconstruct the anterior column of the spine.
STRENGTH
1
200% greater than pure PEEK
OPEN DESIGN
Maximum area for bone graft
and lateral vascularization
PROVEN CLINICAL SUCCESS
CFRP implants have over
a decade of use in the spine2
RADIOLUCENCY
Accurate fusion assessment
CFRP.
Unleash the
Power & Performance
I N D I C A T I O N S
The BENGAL™ Implant System is indicated for use in the
thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral
body resected or excised for the treatment of tumors, to achieve
anterior decompression of the spinal cord and neural tissues, and to
restore the height of a collapsed vertebral body.
BENGAL is also indicated for treating fractures of the thoracic &
lumbar spine.
Open design allows more area
for bone graft-to-endplate contact.
Radiolucent Carbon Fiber Reinforced
Polymer.
Trapezoid shape to fit naturally in
the spine.
Simple and effective instrumentation
for preparation and insertion.
CFRP.
Unleash the
Power & Performance
The BENGAL DePuy AcroMed VBR System is designed to restore the
biomechanical integrity of the anterior, middle and posterior spinal
column even in the absence of fusion for a prolonged period.
The BENGAL DePuy AcroMed VBR System is intended for use with
supplemental internal fixation. The supplemental internal fixation
systems that may be used with the BENGAL DePuy AcroMed VBR
System include DePuy AcroMed titanium plate or rod systems (i.e.,
KANEDA™ SR, UNIVERSITY PLATE™, M-2™ Anterior Plate, ISOLA®, VSP®,
MOSS MIAMI™, TiMX™, MONARCH™, PROFILE™).
Limited Warranty and Disclaimer: DePuy AcroMed products are
sold with a limited warranty to the original purchaser against
defects in workmanship and materials. Any other express or
implied warranties, including warranties of merchantability or
fitness, are hereby disclaimed.
WARNING: In the USA, this product has labeling limitations.
See package insert for complete information.
CAUTION: USA Law restricts these devices to sale by or on the
order of a physician.
DePuy AcroMed is a joint venture with Biedermann Motech
GmbH.
DEPUY ACROMED™, the DePuy AcroMed logo and BENGAL™ are
trademarks of DePuy AcroMed, Inc.
All products are not currently available in all markets.
©2003 DePuy AcroMed, Inc. All rights reserved.
To order, call DePuy AcroMed Customer Service
(1-800-ACROMED).
1. Williams, DF., McNamara, A., Turner, RM. Potential of polyetheretherketone (PEEK) and carbon fiber-reinforced PEEK in medical applications.
Journal of Material Science Letters: 6, 1987; 188-190.
2. Brantigan, JW., et al. The Lumbar I/F Cage for PLIF with VSP pedicle screw
system – Ten year results of a Food and Drug Administration clinical trial.
Accepted for publication at 18th Annual Meeting of National Association
of Spine Surgeons, October 21-25, 2003, San Diego, CA.
DePuy AcroMed, Inc.
325 Paramount Drive
Raynham, MA 02767
IF19-00-000
8/03
JC/QP